Displacement device, testing device and method for leakage testing of a connection of a tip cap with a syringe

Abstract

The present invention relates to a displacement device, DD, for providing a displacement of a syringe closure system for a syringe relative to the syringe, a testing device, TD, and a method for leakage testing of a connection of a syringe closure system for a syringe with the syringe.

The invention claimed is: 
     
       1. A displacement device for providing a displacement of a syringe closure system, SCS, which closes a distal end of the syringe from outside of the syringe, relative to the syringe in an opening direction, a proximal end of the syringe having a flange, comprising:
 a holding unit, HU, for holding at least part of the syringe and 
 a displacement unit, DU, which is movably attached to the holding unit for movement by a predetermined distance in the opening direction, wherein the holding unit comprises: 
 a receiving cylinder for receiving at least part of the barrel of the syringe and 
 a clamping element for clamping at least part of the flange of the syringe between the clamping element and the receiving cylinder, wherein a distal end of the clamping element comprises a clamping surface for contact with a proximal surface of the flange; and 
 wherein the DU comprises a displacement cylinder, DC, movably attached to a portion of the receiving cylinder distal to the flange by a screw type connection. 
 
     
     
       2. The displacement device according to  claim 1 , wherein the receiving cylinder and the clamping element are connected by a screw type connection. 
     
     
       3. The displacement device according to  claim 1 , wherein a proximal inner surface of the receiving cylinder acts as counter surface to the clamping surface. 
     
     
       4. The displacement device according to  claim 3 , wherein the proximal inner surface is perpendicular to the axis of the receiving cylinder or wherein the proximal inner surface is tilted to the axis of the receiving cylinder. 
     
     
       5. The displacement device according to  claim 1 , wherein the smallest inner diameter of the receiving cylinder is larger than or equal to the outer diameter of the barrel of the syringe but smaller than the outer diameter of the flange of the syringe to be held in the displacement device. 
     
     
       6. The displacement device according to  claim 1 , wherein the DU comprises a transmission piece, TP, for transmitting axial movement from the DC to the SCS in the opening direction. 
     
     
       7. The displacement device according to  claim 6 , wherein the TP has the shape of a ring body with a proximal annular protrusion, PAP, along the outer circumference of the ring body. 
     
     
       8. The displacement device according to  claim 6 , wherein the outer diameter of the TP is larger than the outer diameter of the DC. 
     
     
       9. The displacement device according to  claim 6 , wherein the TP has an inner opening and the inner diameter of the inner opening is equal to or larger than the outer diameter of the barrel of the syringe which is to be held in the displacement device and the inner diameter of the inner opening or of a collar provided on the inner opening is smaller than the largest diameter of the SCS. 
     
     
       10. The displacement device according to  claim 6 , wherein the TP has a slot with a direction perpendicular to the axis of TP at a distal end extending from the inner diameter of the inner opening or of a collar to the outer diameter of the TP over the entire radius of the TP, wherein the slot is open at its peripheral end and extends axially over the entire TP. 
     
     
       11. The displacement device according to  claim 10 , wherein the width of the slot and the inner diameter of the inner opening or the inner diameter of the collar correspond to or are larger than the neck of the barrel of the syringe. 
     
     
       12. The displacement device according to  claim 6 , wherein at least a distal end of the DC has a friction reducing coating and/or at least a proximal surface of the TP has a friction reducing coating. 
     
     
       13. The displacement device according to  claim 6 , wherein the TP has a circumferential ball bearing, this circumferential ball bearing being in a plane perpendicular to the axis of the TP. 
     
     
       14. The displacement device according to  claim 1 , wherein at least one scale marking is provided on at least part of the outer circumference of the DC and on the outer circumference of the receiving cylinder. 
     
     
       15. A testing device, TD, for leakage testing of a connection of a SCS for a syringe with the syringe, wherein the testing device comprises a displacement device according to  claim 1 . 
     
     
       16. The testing device according to  claim 15 , wherein the TD comprises an insertion pipe, IP, for insertion into the barrel of the syringe, in particular into the lumen of the barrel and wherein the IP has a channel extending through the IP for providing fluid connection between the lumen of the barrel of the syringe and a detection unit. 
     
     
       17. The testing device according to  claim 15 , wherein the TD comprises a distance piece, DP, movably attached to the IP for setting and holding a distance between the distal end of the IP and the distal end of the lumen of the barrel of the syringe. 
     
     
       18. The testing device according to  claim 17 , wherein the clamping element has a proximal annular extension, PAE, and the outer diameter of the DP, is equal to or smaller than the inner diameter of the PAE of the clamping element. 
     
     
       19. The testing device according to  claim 16 , wherein the IP has at least one sealing ring arranged at the outer circumference of a distal end of the IP, preferably on a sealing head which is screwed onto the distal end of the IP. 
     
     
       20. The testing device according to  claim 15 , wherein the TD comprises a test chamber, TC, detachably connected a body of the TD, and the TC comprises an inlet for input of a testing medium. 
     
     
       21. A method for leakage testing of a connection of a SCS for a syringe with the syringe, wherein the method is carried out with a testing device according to  claim 15  with a displacement device, wherein the displacement device provides a displacement of the syringe closure system, SCS, which closes the distal end of the syringe from outside of the syringe, relative to the syringe in an opening direction, comprising:
 a holding unit, HU, for holding at least part of the syringe and 
 a displacement unit, DU, which is movably attached to the holding unit for movement by a predetermined distance in the opening direction, wherein the holding unit comprises: 
 a receiving cylinder for receiving at least part of the barrel of the syringe and 
 a clamping element for clamping at least part of the flange of the syringe between the clamping element and the receiving cylinder; 
 and wherein the DU comprises a displacement cylinder, DC, movably attached to the receiving cylinder by a screw type connection. 
 
     
     
       22. The method according to  claim 21 , wherein the method comprises the steps of:
 a) placing a syringe with a SCS in a DD, 
 b) placing the DD on a TD, 
 c) placing a TC over the DD, 
 d) evacuating a part of the lumen of the syringe, 
 e) exposing the syringe to testing medium, and 
 f) measuring the amount of testing medium at a detection unit of the TD, which has passed through any leakage between the SCS and the syringe. 
 
     
     
       23. The method according to  claim 22 , wherein step a) comprises the steps of:
 a1) inserting the receiving cylinder into the DC, 
 a2) inserting the syringe with the SCS from the proximal end of the receiving cylinder into the receiving cylinder, 
 a3) clamping the flange of the syringe barrel to the receiving cylinder, and 
 a4) attaching the TP to the distal end of the DC. 
 
     
     
       24. The method according to  claim 22 , wherein step a) comprises a step a5) of
 positioning the TP into an initial position, wherein the TP abuts to the proximal end of the largest diameter of the SCS without applying force to the SCS, by moving the DC relative to the receiving cylinder in the opening direction. 
 
     
     
       25. The method according to  claim 22 , wherein step b) comprises the step of:
 b1) inserting an IP of the TD into the lumen of the syringe barrel and 
 b2) advancing the IP in the lumen of the barrel of the syringe into the vicinity of the shoulder of the barrel of the syringe and 
 b3) moving the DP on the IP to a position, wherein the proximal side of the DD is in contact with the distal side of the DP. 
 
     
     
       26. The method according to  claim 24 , wherein step d) is carried out by applying vacuum to the lumen of the barrel via the IP. 
     
     
       27. The method according to  claim 22 , wherein the method further comprises the step of
 g1) determining whether the measured amount of testing medium which entered the lumen of the barrel exceeds a pre-set threshold value or 
 g2) verifying whether the measured amount of testing medium exceeds a pre-set threshold value at a pre-set distance of the SCS from the initial position in the opening direction. 
 
     
     
       28. The method according to  claim 22 , wherein the method comprises the step h) of moving the DC in the opening direction by a predetermined distance relative to the receiving cylinder. 
     
     
       29. The method according to  claim 28 , wherein the method further comprises the steps of
 i) removing the TC before step h) and 
 j) placing the TC after step h).